Basic Consent Presentation and Documentation

The consent process is more than just handing a participant a form and making sure that their signature is on it.  The consent process should include the following steps:

Introduction to the study

You should provide a copy of the consent form when you meet the potential study participant and discuss the items on the form.  It is important to take the time to help the person understand the study so they can make an informed decision about whether or not to participate.  Be sure to talk about the “What you will do” section in the study with the person so that the participant knows exactly what is involved if they decide to join the study.

Give them Time to Decide

Give the participant some time to think about their participation in a non-pressured environment.  This may be as simple as leaving the room for a moment so that they can go over the document in private.  For studies that involve greater risk to the subject, it may be appropriate for a participant to take the consent document home to think about it and perhaps talk it over with family and friends before agreeing to participate.

Make sure all their Questions have been Answered

Before a participant signs the consent form, give them a chance to ask questions about the study and ask for clarification.  Sometimes participants may be intimidated to ask questions so take time to assess their understanding and make sure that they know what they are agreeing to if they join the study.  For studies that involve greater risk, it may be appropriate to politely ask them to explain what they are agreeing to back to you to assess their readiness to participate. This is called the teach back method and it can help you to clarify their understanding during the consent process.

Consent Documentation

When the participant feels ready, they agree to participate and documents their agreement by signing the consent form. It is good practice for the study team member that discussed the consent with the participant to make a short note that states the date and time the consent discussion occurred, that all the participant's questions were answered prior to their agreement to join the study and to have the study team member sign that they discussed the study with the participant.

Ongoing Consent

The study participant is voluntarily choosing to be in the study and has a right to leave the study at any time. It's important for the study team to remember that the participant has this freedom to leave as part of their ongoing consent.  When the study plan changes the study team should tell the participant about changes that may affect them.  For example, if the participant agreed to 3 study visits and the study team is now adding a 4th visit, then it should be confirmed the participant agrees to complete the newly added 4th visit. Because consent is an ongoing process, open dialog and clear communication between the study team and the participant should continue to occur throughout the participant's time in the study.